Usability Engineering for Medical Devices
Clinical Performance Studies under the IVDR – What’s required, what has changed?
Usability is an important requirement for medical devices under the European Union’s Medical Devices Regulation (EU MDR). The EU MDR requires medical devices to be designed and manufactured in such a way that they are safe and easy to use for their intended purpose, including by their intended user groups.
When it comes to medical devices, usability is not only considering ease of use. It’s more about enabling and ensuring the safe use of the device. In fact, the industry standard for usability engineering of medical devices is IEC 62366-1, which defines usability as a characteristic of the user interface that facilitates use, increases effectiveness and efficiency, and leads to user satisfaction in the intended use environment.
But what exactly is the usability engineering? It is a process that allows manufacturers to assess and mitigate risks associated with correct use during normal use. It is an essential part of the design control and risk management processes that ensure the safety and effectiveness of medical devices.
Support & Training
Contact AKRA TEAM for support, hands on implementation services and personalized training by experts with key competencies in the areas listed below.
Key steps for usability under the EU MDR include:
Manufacturers must identify and document the user needs and requirements for their medical device, including the characteristics of the intended user groups and their use environments. By understanding these factors, you’ll be able to identify what can go wrong with regards to safety and the user interface of the device.
- Usability procedure/process
- Device usability plans
- Formative usability testing protocols and reports
- Summative usability testing protocols and reports
- Device usability summary reports